MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD VIAL ADAPTER 13MM LONG W/25MIC FILTER-VF

Catalog Number 8070201

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, the customer, novo nordisk, contacted west pharma.Services, il ltd.(west il), to report that during quality control of lot f759, one (1) retention sample of the vial adapter 13 mm, was found to have visible black particles within the seal of the packaging and also on the inside of the packaged device.The event was discovered prior to patient use.

Manufacturer Narrative

West pharma.Services il, ltd.(west il) is currently investigating this complaint.The device will not be returned to west il for an evaluation.However, a photograph was provided to west il with visible particles as reported inside of the packaged device.Upon completion of the west il investigation and if additional information is provided from the customer a follow up report will be submitted.

Manufacturer Narrative

West pharma services il (west il) investigated a complaint received by novo nordisk, regarding observed black particles within the seal of the packaged vial adapter 13mm.The affected sample was not returned to west il for evaluation, therefore, the nature of the particle could not be determined.According to a photo provided by the customer, the reported particle does not cross the sealing area and no particles were observed inside the blister pack.Batch records review was performed on lot number f759 and no issues were noticed.This lot was manufactured according to relevant procedures, tested before release, and shipped according to specifications.Retained samples of lot number f759 were visually inspected no issues were noticed.West il sent a formal request for investigation to the sub-contractor.According to the sub-contractor, retained samples from lot#f759 were 100% visually inspected, no findings were observed.As the sample was not sent by the customer to west il, the complaint subject could not be fully investigated.Therefore, according to available information, the probable root cause could not be determined.

• Brand Name: VIAL ADAPTER 13MM LONG W/25MIC FILTER-VF
• Type of Device: VIAL ADAPTER
• Manufacturer (Section D): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf street; ra'anana, 43664 11; IS 4366411
• Manufacturer (Section G): WEST PHARMA. SERVICES IL, LTD; 4 hasheizaf street; ra'anana 43664 11; IS 4366411
• Manufacturer Contact: lynn lundy ; 530 herman o. west dr; exton, PA 19341 ; 4848853298
• MDR Report Key: 17817781
• MDR Text Key: 324260782
• Report Number: 3000223297-2023-00015
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 07290108240245
• UDI-Public: 07290108240245
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K963583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 8070201
• Device Lot Number: F759
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 11/19/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1